Overview:
The number of medical device recalls was up 28% in 2013 and estimated to be even higher in 2014. Learning to design for durability using risk analysis tools the right way at right time can eliminate many life cycle costs such as production rejects, rework, warranty costs, safety litigation costs, and maintenance and repair costs to customers. Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.
Why should you Attend: A critical and sometimes overlooked aspect of designing medical devices is the inability to implement systems thinking. Usually the specifications are flawed, designs are flawed, manufacturing requirements for defect-free production are flawed, and integration among users, suppliers, and interfaces is flawed.
Systems thinking is not a panacea that can prevent every mistake, but it a best known tool that helps us design for zero failures for a long time and help us see many robust solutions to eliminate risks including warranty costs. Unlike the limited single focused cause-and-effect approach, the systems thinking is about relatedness of individual causes to system causes, interdependencies on the knowledge of cross functional teams, interdependencies on the knowledge of manufacturers and device users, and understanding what you don’t know about device durability.
Areas Covered in the Session:
- Introduction to medical device quality requirements
- Writing specifications for long life free of failures
- Correctly using risk assessment
- Risk mitigation for long life
- Avoiding mistakes during early design
- Using system functions fmea
- Fault tree analysis to prevent adverse events
- Verifications during the detail design
- Preventing manufacturing defects by designusing design validation for long life
- Post production monitoring the risk to patients
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
support@compliance4all.com
www.compliance4all.com
Comments